Serious Adverse Events in Pediatric Surgery: A French Nationwide Study

Adverse events (AE) are a major source of preventable morbidity and mortality in surgery. Pediatric surgery combines surgical complexity with vulnerabilities specific to childhood. However, specific data on AE in this field remain limited. This study aims to describe AE in pediatric surgery and to identify factors associated with serious adverse events (SAE).

Using a national prospective clinician-reported database, all AE reported between June 2016 and August 2024 were analyzed. Event severity was classified according to the Clavien-Madadi grading system, with SAE defined as grades ≥ III. Contributing factors were assessed using the Association of Litigation And Risk Management systemic analysis framework. Statistical analyses were performed to identify factors associated with the occurrence of SAE.

A total of 706 AE were reported, mainly involving boy (71.0%) with a median age of 3 years (IQR, 1-10). Most AE occurred in the operating room (52.7%) during scheduled procedures (73.5%) and were considered preventable (94.3%). Eighteen percent of AE were classified as severe. Independent factors associated with SAE included older age (OR=1.04, p=0.037), complex clinical situation (OR=2.62, p<0.001), scheduled care (OR=0.55, p=0.010), and patient-related factors (OR=1.62, p=0.035). Infections were more frequent among SAE (12.8% vs 2.29%, p<0.001). Overall mortality was 0.8%. Safety barriers failed in 56.7% of SAE.

Serious adverse events in pediatric surgery mainly occur in unplanned, complex situations and are frequently preventable. Our study highlights patient-related vulnerabilities as major contributors to severity.